Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

Completed · Phase 3 · Has a placebo group

Conditions studied: Short Bowel Syndrome

In brief

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Key facts

Study ID

NCT04627025

Run by

VectivBio AG

People needed

164

Starts

2021-01-26

Expected to finish

2024-02-22

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent for this trial prior to any trial specific assessment.
• Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
• Subject must require PS at least 3 days per work and be considered stable.
• No restorative surgery intended to change PS requirements in the trial period.
• Age ≥18 years at screening.

You may not qualify if…

• Pregnancy or lactation.
• Major abdominal surgery in the last 6 months prior to screening.
• History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
• Evidence of active inflammatory GI conditions in the previous 6 months.
• Evidence of decompensated heart failure.
• Evidence of severe renal or hepatic impairment.
• Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.

Where it is running

• Gastroenterology Group of Naples — Naples, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Henry Ford Medical Center - Columbus — Novi, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center, Center for Human Nutrition — Nashville, Tennessee, United States
• University of Washington Medical Center — Seattle, Washington, United States
• University Hospital Foundation Favaloro — Buenos Aires, Argentina
• Universitair Ziekenhuis Leuven - Gasthuisberg — Leuven, Vlaams Brabant, Belgium
• University Hospital Brussels — Brussels, Belgium
• University Hospital Brno — Brno, Czechia
• University Hospital Hradec Kralove — Hradec Králové, Czechia
• Hospital Novy Jicin — Nový Jičín, Czechia
• University Hospital Plzen — Pilsen, Czechia
• University Hospital Kralovske Vinohrady, 2nd Internal Clinic — Prague, Czechia
• General University Hospital in Prague — Prague, Czechia
• Rigshospitalet - University Hospital Copenhagen — Copenhagen, Denmark
• Hôpital Beaujon — Clichy, France
• CHU Hôtel Dieu — Nantes, France
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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